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BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Baxter
Harvard Business School
Federal Trade Commission
Farmers Insurance
McKesson
Express Scripts
Daiichi Sankyo
McKinsey
Deloitte
Merck

Generated: November 19, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090951

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NDA 090951 describes EPINASTINE HYDROCHLORIDE, which is a drug marketed by Apotex, Sun Pharm Inds, Somerset Theraps Llc, Akorn, Breckenridge Pharm, and Sandoz Inc, and is included in six NDAs. It is available from five suppliers. Additional details are available on the EPINASTINE HYDROCHLORIDE profile page.

The generic ingredient in EPINASTINE HYDROCHLORIDE is epinastine hydrochloride. There are six drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the epinastine hydrochloride profile page.

Summary for 090951

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Ophthalmic Agents

Pharmacology for NDA: 090951

Suppliers and Packaging for NDA: 090951

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EPINASTINE HYDROCHLORIDE
epinastine hydrochloride
SOLUTION/DROPS;OPHTHALMIC 090951 ANDA Somerset Therapeutics, LLC 70069-008 70069-008-10 10 CARTON in 1 CARTON (70069-008-10) > 1 BOTTLE in 1 CARTON (70069-008-01) > 5 mL in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.05%
Approval Date:Oct 31, 2011TE:ATRLD:No


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Serving leading biopharmaceutical companies globally:

US Department of Justice
Citi
Chinese Patent Office
Farmers Insurance
Federal Trade Commission
Argus Health
Merck
McKinsey
Johnson and Johnson
Cantor Fitzgerald

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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